lycopene + docetaxel

**Lycopene + Docetaxel** is a combination therapeutic approach being investigated for the treatment of prostate cancer, particularly in advanced, castrate-resistant disease. Lycopene, a carotenoid, is combined with docetaxel, a standard chemotherapeutic agent. Preclinical studies in animal models suggest that lycopene enhances the anti-prostate cancer efficacy of docetaxel. Clinical trials have evaluated this combination. A phase I trial (NCT0149519) in men with metastatic prostate cancer established the maximum tolerated dose (MTD) of synthetic lycopene at 150 mg/day when combined with docetaxel and androgen blockade therapy. This study also found that lycopene increased the plasma exposure (AUC) of docetaxel by 9.5% and its maximum concentration (Cmax) by 15.1%, indicating a potential pharmacokinetic interaction. The combination showed low toxicity in this phase. A phase II study in advanced castrate-resistant prostate cancer demonstrated promising clinical activity: a PSA response rate of 76.9%, a disease control rate of 92%, a median time to PSA progression of 8 months, a median duration of response of 7.3 months, and a median overall survival of 35.1 months. The combination appears to exert its effects through several mechanisms, including lycopene accumulation in prostate tissue, inhibition of signaling through the IGF-1 axis, reduction of IL-6 levels, modulation of angiogenesis markers such as vascular endothelial growth factor A (VEGF-A) and circulating endothelial cells, and reduction in insulin-like growth factor 1R (IGF-1R) phosphorylation. The safety profile appears favorable, with common adverse events in the phase II study being diarrhea, nausea, vomiting, peripheral neuropathy, weight loss, fatigue, onycholysis, and alopecia. Febrile neutropenia occurred in one patient, but grade 3 or above anemia was not observed. Dose-limiting toxicity was infrequent in the phase I trial.

Other names

lycopene and docetaxelsynthetic lycopene + docetaxel